NEW HAVEN, Conn., July 11, 2019 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced
it will present 16 scientific presentations (oral and poster)
highlighting new efficacy and safety data for rimegepant from
Biohaven's robust clinical development program at the American
Headache Society (AHS) Annual Scientific Meeting in Philadelphia, July
11-14, 2019. Notably, Biohaven will be presenting results
from the rimegepant Zydis® oral fast-dissolve tablet (ODT)
Phase 3 trial, new analyses across the three Phase 3 trials,
results from the rimegepant long-term safety study, and new
clinical pharmacology data. Rimegepant is an oral, single dose,
selective and potent small molecule calcitonin gene-related peptide
(CGRP) receptor antagonist in development for the acute treatment
of migraine.
"Through 16 presentations at AHS, the premiere national
annual headache conference, we are sharing the most extensive
positive data set on rimegepant as an acute treatment of migraine,"
said Vlad Coric, M.D., Chief
Executive Officer of Biohaven. "These studies demonstrate that
rimegepant is effective for the acute treatment of migraine across
multiple patient subsets, including difficult to treat patients
with more frequent attacks and those taking concurrent preventive
migraine medications as well as patients experiencing nausea."
Richard Lipton, MD, Professor and
Vice Chair of Neurology at the Albert Einstein College of Medicine
and Montefiore Health System, Director of the Montefiore Headache
Center will present the positive results from the randomized,
controlled Phase 3 clinical trial (Study 303) evaluating the
efficacy and safety of rimegepant Zydis ODT for the acute treatment
of migraine on Saturday, July 13 from
8:40 AM ET – 8:50 AM ET (Oral Presentation #IOR05). Dr. Lipton
is also a paid consultant and shareholder of Biohaven.
Consistent with the two previous Phase 3 clinical trials for
rimegepant oral tablet, Study 303 met its co-primary endpoints of
pain freedom and freedom from the most bothersome symptom at two
hours using a single dose. Importantly, patients treated with the
rimegepant Zydis ODT formulation began to experience pain relief as
early as 15 minutes, with numerical separation from placebo, and
this difference was statistically significant at 60 minutes
(p=0.0314). Additionally, a significantly greater percentage of
patients treated with rimegepant Zydis ODT returned to normal
functioning by 60 minutes as compared to placebo
(p=0.0025). Furthermore, sustained clinical benefit was
observed through 48 hours after a single dose of rimegepant on
freedom from pain (p<0.0001), pain relief (p<0.0001), freedom
from the most bothersome symptom (p=0.0018), and freedom from
functional disability (p<0.0001). Superiority over placebo was
also demonstrated on additional, clinically relevant secondary
endpoints. The vast majority of patients treated with rimegepant
Zydis ODT (85%) did not use any rescue medications.
"The results of the Phase 3 study of rimegepant Zydis ODT for
the acute treatment of migraine demonstrate the meaningful benefits
of this easy-to-use single-dose formulation, with early and
sustained relief of symptoms, low use of rescue medications, and
low rates of adverse events," said Dr. Lipton. "A new effective,
safe, and convenient acute treatment option would be a great
advancement for the millions of people around the world whose daily
lives are impacted by migraine."
There are a total of 15 additional rimegepant posters being
presented at AHS. Posters include:
- Poster #P235LB: Interim results from the long-term, open-label
safety study of rimegepant 75 mg in over 1,780 patients with a
combined exposure of over 105,000 doses are being presented for the
first time at a scientific meeting. Patients were dosed up to one
year and were allowed to take rimegepant up to once daily. The drug
was well tolerated in adults with migraine, only 2.7% of subjects
discontinued due to an adverse event, and there were no signs of
hepatoxicity. A cohort with high-frequency, scheduled dosing of
rimegepant 75 mg at least every other day demonstrated consistent
results with the overall population. Exploratory efficacy analyses
from this study demonstrate that rimegepant reduces migraine days
when used on an as-needed basis for acute treatment of attacks as
well as when dosed on a scheduled basis, suggesting that rimegepant
may have dual-therapy action with acute and preventive treatment
effects.
- Poster #P239LB: A pooled analysis of results from the three
rimegepant Phase 3 trials looked at the efficacy of rimegepant in
patients taking concurrent preventive medication and found
rimegepant to be more effective than placebo for the acute
treatment of migraine. Among subjects on preventive medication (547
subjects, rimegepant n=272, placebo n=275), pooled two-hour pain
freedom rates for rimegepant and placebo were 20.6% and 10.2%,
respectively (p=0.0007). Additionally, the two-hour rates for
freedom from most bothersome symptom were 37.1% for rimegepant and
20.4% for placebo (p<0.0001).
- Poster #P236LB: A pooled analysis of results from the three
rimegepant Phase 3 trials looked at the efficacy of rimegepant in
patients with high migraine attack frequency (at least four attacks
per month), a patient population that has previously been shown to
be more difficult to treat, and found rimegepant was an effective
acute treatment of migraine. Among subjects with ≥4 moderate or
severe attacks per month (2426 subjects, rimegepant n=1217, placebo
n=1209), two-hour pain freedom rates for rimegepant and placebo
among these patients were 20.6% and 12.6%, respectively
(p<0.0001). For two-hour freedom from the most-bothersome
symptom, the rates were 35.8% and 26.9% for rimegepant and placebo,
respectively (p<0.0001).
- Poster #P238LB: The first clinical report evaluating the
efficacy and safety of rimegepant for the acute treatment of
migraine for breakthrough attacks in two patients concurrently
receiving erenumab, a CGRP receptor binding monoclonal antibody,
for preventive treatment of migraine is being presented for the
first time in a scientific meeting. The two patients were enrolled
in the rimegepant long-term open-label safety study. With
rimegepant used as an acute treatment, both patients were able to
eliminate use of additional rescue medications and successfully
treat their attacks with rimegepant alone. After starting erenumab
for preventive treatment, both patients were able to successfully
treat breakthrough attacks with oral rimegepant that occurred
despite the use of the injectable monoclonal antibody preventive
therapy.
About Rimegepant
Rimegepant is Biohaven's orally-dosed calcitonin gene-related
peptide (CGRP) receptor antagonist, which the Company is developing
as a treatment for migraine. Rimegepant represents a novel
mechanism that targets the underlying pathophysiology of migraine
without causing vasoconstriction. The efficacy and safety profile
of rimegepant for the acute treatment of migraine has now been
established across four randomized controlled trials to date: the
three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in
all three Phase 3 trials are consistent with regulatory guidance
from the FDA for NDA submissions provide the basis for the NDA
submissions to the FDA.
About Biohaven
Biohaven is a clinical-stage biopharmaceutical company with a
portfolio of innovative, late-stage product candidates targeting
neurological diseases, including rare disorders. Biohaven has
combined internal development and research with intellectual
property licensed from companies and institutions including
Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and
Massachusetts General Hospital. Currently, Biohaven's lead
development programs include multiple compounds across its CGRP
receptor antagonist, glutamate modulation and myeloperoxidase
inhibition platforms. More information about Biohaven is available
at www.biohavenpharma.com.
Forward-Looking Statements
This news release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements involve substantial risks and
uncertainties, including statements that are based on the current
expectations and assumptions of the Company's management. All
statements, other than statements of historical facts, included in
this press release regarding the Company's business and product
candidate plans and objectives are forward-looking statements.
Forward-looking statements include those related to: the
effectiveness and safety of rimegepant, the expected timing,
commencement and outcomes of the Company's planned and ongoing
clinical trials, the timing of planned interactions and filings
with the FDA, the timing and outcome of expected regulatory
filings, the potential commercialization of the Company's product
candidates and the potential for the Company's product candidates
to be first in class or best in class therapies. The use of certain
words, including "believe", "continue", "may", "on track",
"expects" and "will" and similar expressions, are intended to
identify forward-looking statements. Various important factors
could cause actual results or events to differ materially from
those that may be expressed or implied by our forward-looking
statements. Additional important factors to be considered in
connection with forward-looking statements are described in the
"Risk Factors" section of the Company's Annual Report on Form 10-K
filed with the Securities and Exchange Commission on February 28, 2019 and the Company's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, filed with the Securities and
Exchange Commission on May 8, 2019.
The forward-looking statements are made as of this date and the
Company does not undertake any obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
For further information, contact:
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
For Media:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
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